This document provides guidance on appropriate use of the ColonRing device for colorectal anastomoses. It discusses checking patient and surgical factors before use, such as bowel prep, comorbidities that may impact healing. It also addresses potential issues that may be encountered like mucous plugs, foreshortened bowel, or thick fibrotic tissue. The document provides accommodations for different situations like diverting ostomies or modifying the anastomosis technique. It aims to help users safely and properly apply the ColonRing device for colorectal anastomoses.

1. The Next Era in GI Surgery BioDynamixTM Anastomosis The Colon Ring DIFFICULT SITUATIONS Clinical Training Team BEWARE!! Shark-infested Waters

2. 2 Appropriate Use of ColonRingTM Check w/ surgeon before case to see if ColonRingTM is appropriate to use— Ileostomy closure (above ileocecal valve)— Right hemicolectomy (not initial case)— Bowel prep— Patient co-morbid conditions—

4. 5 Appropriate Use of ColonRingTM Check w/ surgeon before case to see if ColonRingTM is appropriate to use— Bowel prep— What may happen? Hard stool proximally may force premature evacuation of the ring complex. What should be should be suggested? Minimum required: 1-2 Fleets enemas preop, stool softeners 2 days preop & 7 days postop.

6. Colonic lavage

8. 8 Appropriate Use of ColonRingTM The ring complex is “smart” regarding the necrotic process, but it is unaware of the stage of the surrounding healing process!

9. 9 Appropriate Use of ColonRingTM But, what if the surgeon advises you that the patient has requested confidentiality of diagnosis? Ask if there is any history or evidence of delayed healing.

10. 10 Appropriate Use of ColonRingTM In the presence of delayed healing— Emphasize benefit of proximal diversion. “When in doubt, skip out!”

11. To Divert or Not to Divert…That is the Question! Why to divert?— Diversion definitely decreases the severity of anastomotic leaks! Why not to divert?— Consequences of unnecessary stomas— Second surgery required Necrosis or retraction of stoma Prolapse or peristomal herniation Social implications Difficulties in care: leakage, appliance application Odor Appearance under clothing 11

12. 12 Colostomy Closure Colostomy closure (primarily Hartmann reversal)— This procedure may frequently cause more potential problems than expected due to various factors mostly related to the delay between the initial operation and the subsequent closure. What might you suspect if it is noted that the applier does not appear to insert fully to the distal rectal stump or the orange mark at the base of the trocar is not seen? Mucous plugs—

13. 13 Colostomy Closure – Mucous Plugs Mucous plugs— What is a mucous plug? Mucus becomes inspisated (dried out & hardened like concrete). What is the effect of mucous plugs? May present difficulties with closing the device. May prevent device from advancing to end of rectal stump. May prevent device from closing completely. Accommodation: Preoperative enemas Intraoperative endoscopy & removal End-to-side (anterior) anastomosis

14. 14 Colostomy Closure—Fore-shortened Segment Colostomy closure— What can happen with a bowel segment not used for a long period? Fore-shortened segment— Lack of stool passage through the distal segment often results in contraction of the segment. What problems will this present? Less length is available for anastomosis. Thicker wall results due to contraction. Accentuated interference from valves of Houston. Accommodation: Re-dissection of perirectal space will help. Additional splenic flexure takedown may be required.

15. 15 Colostomy Closure – “Strictured” Areas Colostomy closure— What additional problem may prevent insertion of applier into rectal segment? “Strictured” areas— Previously mentioned fore-shortening may lead to apparent “strictured” areas which are actually tortuosities of the lumen rather than true strictures, but they may still make introduction of the device difficult. Accommodation: Re-dissection of perirectal space will help. Introduction of 28 mm dilator should assure adequate entry.

16. 16 Colostomy Closure – Thick Fibrotic Tissue Colostomy closure— Thick fibrotic tissue— What is the problem with this situation? Fibrosis of the prior staple line usually results in fibrotic, thickened, minimally compressible end of distal rectal stump which may cause difficulty in forming an appropriate anastomosis. Accommodation: Resection of fibrotic staple line area; restaple or purse-string. End-to-side (anterior) anastomosis.

17. 17 Ring Loading Problems Ring loads improperly on the applier— Often due to excessive pressure applied during loading, especially if the ring is rotated excessively, stripping the plastic locking tabs. May result from too little or unequal pressure on loader. Accommodation: Demonstrate proper loading techniques before procedure to involved individuals.

18. 18 Anvil Retention Problems The anvil will not remain secured to the trocar— Usually due to excessive tissue present between the anvil and ring. Most often seen with reversal of Hartmann. May result with use of double purse-strings. Accommodation: Resect excessive tissue around purse-strings. Resect fibrotic distal staple line in Hartmann reversal. Perform side-to-side, end-to-side, or side-to-end anastomosis. Assist closure of device with gentle pressure on anvil head.

19. 19 Improper Mating of Anvil & Trocar When is the anvil seated properly? When does the anvil lock in place? Can the device be fired without the anvil properly attached to the trocar? Can the cutting handles be fired? Will the anastomosis be formed? Can the device be opened? Will the ring remain attached to the applier? When does the mechanism actually push the ring off the device handle? When you notice the anvil and trocar fail to mate and separate, at what point would you need to take the device out to be sure the ring is still firmly seated before reconnecting the trocar and anvil and continuing?

20. 20 Improper Cutting of Anvil Head Blade won’t cut anvil head after ColonRingTM and anvil head are mated— What may have happened? Incomplete closure of device. Lack of depression of cutting trigger. Incomplete firing of cutting handle. Instrument failure.

21. 21 Proper Cutting of Anvil Head – No Anastomosis! Blade cut anvil head after firing ColonRingTM handles but no anastomosis is formed— What may have happened? Most likely ColonRingtm was not loaded on applier!!! Accommodation: Assure that surgeon always checks to make sure that the ColonRingtm has been properly loaded before attempting to insert the applier.

22. 22 Cross-Utilization of Parts Cross-utilization of parts of two separate ColonRing units— What may happen? Potential for improper result is higher. Devices are tested as a complete unit.

23. Difficulty in Withdrawing Applier If withdrawal of the applier appears to place traction on the anastomosis— Consider possibility of “vacuum” in rectal segment— Support distal side of anastomosis. 23

24. Difficulty in Withdrawing Applier If withdrawal of the applier appears to place traction on the anastomosis— Applier remains attached to ring complex— Attempt repeat cutting with cutting handle; If success— Additional testing. Visualization of anastomosis?? Diversion?? If no success— Open applier proximal to warning “click”. Remove anastomosis anvil/ring complex from trocar. Close applier distal to warning “click”. Remove applier. Resect anastomosis and re-do. 24

25. 25 Increased Size of Bowel Lumen If the size of the proximal bowel lumen appears too large— Consider removing excess tissue around the purse-string to prevent an improper anastomosis. Consider placing the anvil through the side of the proximal segment (and secure it with a quick purse-string).

26. 26 Decreased Size of Bowel Lumen In the presence of a lumen appearing smaller than 27 mm— Open along anti-mesenteric border Bring anvil out through side of intestine (Recommend quick purse-string)

28. Manual or endoscopic removal is likely to be required.

29. Surgical removal may be necessary.Accommodation: Consider end-to-side anastomosis (anterior) below “stricture”. Resect close to stricture and complete anastomosis as desired. 27